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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule
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Organ Procurement and Transplantation: Assessing Current Policies and the Potential Impact of the DHHS Final Rule
Index
A
Access to quality health care, 39, 40, 47
Access to transplantation
current system performance, 1, 11
determinants of, 6-7, 12, 39, 45, 47
Final Rule effects, 3, 27-28, 46
Final Rule goals, 2, 26
Medicaid as factor in, 45-46
OPTN responsibilities in improving, 26
patient's travel distance as factor in, 44-45
socioeconomic differences in, 39-40, 41
waiting time as measure of, 10
Accountability, 131, 132
African Americans
access to transplantation, 39, 40, 41, 42, 44
donation rate, 33
histocompatibility testing, 42
organ donation rates, 51-52, 53, 56
posttransplant survival rate, 42, 98
transplantation patterns, 11
waiting times, 40
Age of donors, 50, 51
graft survival risk, 93
Age of transplant patient
likelihood of transplantation and, 86
posttransplant survival rate, 98
pretransplantation mortality risk, 86
status 1 patient outcomes, 69, 86
status 2 patient outcomes, 72, 86
status 3 patient outcomes, 76, 86
Allocation
current concerns, 2, 36, 38
current system, 5, 34-37
Final Rule goals, 2, 24
patient status as criterion for, 36-37
policies, effects on donation rates, 52-53
policy development, 25-26
recommendations for criteria, 90
system evaluation, methodology for, 6
system evolution, 18-19
waiting time as criterion for, 10-11, 35, 87, 90
See also Organ allocation areas
Alternative local units, 32
Asian donors, 51
Assessment, medical
cost of, 124
current inadequacies in, 24, 36
determination of organ acceptability, 93
standardization, 26, 36
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B
Belzer UW solution, 17
Biological constraints
data collection for evaluating, 94
retrieval and preservation of organs, 91
size of organ allocation areas, 94
Blood type
posttransplant survival rate and, 98
pretransplant mortality, 86
status 1 patient outcomes, 69, 86
status 2 patient outcomes, 72, 86
status 3 patient outcomes, 76, 86
transplantation rate and, 86
Bone marrow transplantation. See National Marrow Donor Program
C
Caucasian donors, 50
Cold ischemic time. See Ischemic time
Compliance, medication, 41
Computer simulation, 95-96
Confidentiality, 3, 28
CONSAD computer model, 96
Cost of transplantation
components, 123, 124, 130
data sources, 124
definitions, 123
determinants of, 13
effects of broader sharing, 123, 129-130
Final Rule effects, 3, 13-14, 27-28, 123, 127, 128, 129, 130
organ acquisition, 129-130
per transplant, 124
posttransplantation compliance, 41
severity of patient illness, 127-129
sources of variation, 124
D
Delayed graft function, 92
Demand for organ transplantation, 2, 17-18, 51
Donation rates, 2
correlates of, 51-52
current status, 50-51
demand and, 18, 51
determinants of, 12, 33, 49, 50, 56, 59
donor age, 50
educational interventions to increase, 53, 56
effects of allocation policies, 52-53
effects of broader sharing, 49, 50, 51, 52-53, 59
Final Rule effects, 3, 12, 27-28, 49
growth of, 18, 50, 51, 53
OPO performance evaluation, 58-59
potential, 50, 58
racial differences, 50-52, 53, 56
strategies to increase, 56-58, 59
E
Equity in allocation
current concerns, 2, 23
current system performance, 1
determinants of, 12
outcome variations by patient status, 68, 78, 86
socioeconomic differences in access, 39-40
F
Family of organ donor
decision making processes, 51
outreach strategies to increase organ donations, 56-57
Final Rule
concerns about, 3, 26-27
effects on access, 11-12, 39-40, 46
effects on cost, 13-14, 123, 127, 128, 129, 130
effects on donation rates, 12, 49
effects on patient survival rate, 12-13
effects on small transplant centers, 43-45, 46
effects on waiting times, 3, 27-28, 61
goals, 2-3, 23, 26
liver allocation policies, 25
major provisions, 24-25
mandated review, 3, 27-29
monitoring, 95
origins of, 23
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policy development provisions, 25-26
procedural requirements, 25
recommendations for allocation, 6, 10
text, 25
Follow-up, posttransplant
medication compliance, 41
posttransplant survival rate and, 98
Funeral expenses, 58
G
Gender differences, 86
posttransplant survival rate, 98
Geographical area of transplantation
current concerns, 2, 24
current liver allocation policy, 25, 37
current system, 5
effect on donor behavior, 12, 50, 52-53
regional variation in waiting times, 62
size, 1
system evolution, 19, 22-23
See also Organ allocation areas
H
Health and Human Services, Department of, Final Rule, 2, 3, 23, 24 -25
information management role, recommendations for, 15, 135
National Organ and Tissue Donation Initiative, 18
OPO standards, 34
oversight role, recommendations for, 14, 133
scientific review of transplantation system, 133
Health Care Financing Administration, 18, 34, 57
OPO oversight, 58, 132
Heart transplantation, 29
Medicaid coverage, 45
pretransplantation mortality, 93
primary nonfunction, 91
survival rates, 17
Hispanic patients
access to transplantation, 44
organ donation rates, 50-51
Histocompatibility testing, 42
I
Immunosuppressive medications, 41
Information management
computer simulation of allocation system, 95-96
cost data, 124
current inadequacies, 14, 131, 133-134
distribution of data, 134
Final Rule goals, 2-3, 24
goals, 132
impact of biological factors, 94
organ recovery and distribution, 94
outcomes data, 94, 132-133
public access, 25, 134
recommendations for, 15, 131, 134-135
regular review of procedures and performance, 134
scientific review of transplantation system, 133
for system oversight, 131-132
for system performance evaluation, 134
transplant center-based measures, 95
See also Performance measures
Insurance, access to transplantation and, 12, 39, 47
Ischemic time, 12
current knowledge and transplant practice, 92, 93-94, 98-99
definition, 17, 91
maximal achievable, 93
medically acceptable, 93
negative outcomes related to, 91, 92
organ sensitivity, 91
primary nonfunction and, 91
significance of, 17
strategies to reduce, 92
K
Kidney transplantation, 91
Medicaid coverage, 45
racial differences, 39-40, 41, 42
socioeconomic differences, 41
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L
Legal liability, 3, 28
Length of stay, 127-128
Liver transplantation
allocation criteria, 25, 34, 35-37
organs recovered but not transplanted, 95
reducing retransplantation risk, 92
as unit of analysis, 28-29
Local units, 32
Lung transplantation, 29
Medicaid coverage, 45
survival rates, 17
M
Marginal donors, 93
Match system, 34-35
definition, 32
Medicaid, 22
access to transplantation and, 45-46
mandated referrals for organ donation, 57
Medicare, 18, 22
Final Rule effect on expenditures, 128
mandated referrals for organ donation, 57
performance standards, 132
Minority populations
access to transplantation, 2, 11-12, 39-40, 44
Final Rule review, 27-28
See also specific racial or ethnic group
Mortality. See Pretransplantation mortality; Survival rate, posttransplant
Multiple organ transplants, 36
N
National Marrow Donor Program, 95
National Organ and Tissue Donation Initiative, 18
National Organ Transplant Act of 1984, 2, 14, 17, 22
O
Omnibus Budget Reconciliation Act of 1986, 22, 57
OPOs. See Organ procurement organizations
OPTN. See Organ Procurement and Transplantation Network
Organ allocation areas
biological constraints, 94
computer simulations, 96
costs of increasing, 123, 129-130
effect on donor behavior, 12
patient education, 90
population size, 7, 61, 88
rationale for, 87-89
recommendations for, 6-7, 89-90
Organ Procurement and Transplantation Network (OPTN)
allocation policy, 36-37
board composition, 25-26
criticisms of governance structure, 38
current system, 5
Final Rule provisions, 24-25, 46
historical evolution, 22-23
information management, 25, 134-135
performance measures, 133
performance review, 132
policy development, 25-26
recommendations for, 15, 134-135
review of policies and procedures, 3, 23
transition to new policies, 25
Organ procurement organizations (OPOs)
administration and management, 33
certification, 18, 34
costs of organ procurement, 129-130
current system, 4
definition, 32
function, 4, 32, 33
historical evolution, 18-19, 22
host, 32
number of, 7, 32
oversight, 18, 25, 33, 58
performance standards, 34, 58-59, 132, 133
responsibilities, 19, 33, 49
service area requirements, 33
sharing agreements, 33-34
effects on transplantation rate, 82, 85
recommendations for, 89-90
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size of
distribution, 78
distribution of patient status levels, 81-82
historical evolution, 19
rationale for minimum organ allocation areas, 87-89
transplant outcomes and, 78, 81, 86
transplantation rate and, 7, 78, 81-82, 86
variation in posttransplantation mortality among, 70, 74
variation in pretransplantation mortality among, 69-70, 74, 76
variation in transplantation rate among, 6-7, 69, 70, 72, 74, 76, 78, 81-82, 85, 86-87
variation in waiting times among, 61, 67, 68, 72, 74, 86, 88-89
volume of
posttransplant survival rate and, 91, 98, 99
transplant outcomes related to, 6-7, 12-13, 72, 76, 86, 88
transplantation rate and, 6, 72, 74, 76, 86, 87-88
waiting time effects on, 72
Oversight
federal role, 131-132, 133
OPO certification, 18
OPO performance standards, 34, 58-59
OPO service area requirements, 33
OPTN role, 25
participants, 131
recommendations for, 14, 131, 133
scientific review of transplantation system, 133
P
Pancreas transplantation, 45
Payment for donations, 58
Performance guidelines, 95
Performance measures, 14
outcomes, 132-133
purpose, 132
recommendations for, 131, 133
review of current, 132
waiting times as, 1, 7, 10, 61, 88
Posttransplantation mortality. See Survival rate, posttransplant
Pretransplantation mortality, 1
effects of OPO sharing agreements, 82, 83
as indicator of access, 10
national organ sharing and, 96
OPO size and, 78, 81
OPO volume and, 6, 7
patient age and, 86
variations among OPOs, 69-70
variations by patient status, 68, 69-70, 71-72, 74, 76, 82, 85, 86 , 87
waiting time and, 72
Primary nonfunction
definition, 91
ischemic time limits, 92
reducing risk of, 92
Pritsker computer model, 96
Procurement of organs
costs, 123, 129-130
determination of organ acceptability, 93
factors affecting organ availability, 50
OPO responsibilities, 4, 19, 49
process, 49
reducing retransplantation risk in, 92
system evolution, 18-19
Public awareness campaigns, 53, 56, 58
Q
Quality assurance, 95, 131
Quality control, 95
R
Recovery and preservation of organs
biological factors in, 91
costs, 129-130
current policies and procedures, 4
data collection, 95
organs recovered but not transplanted, 95
responsibility for, 4, 129
surgical procedure, 129
Required request legislation, 56-57
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Retransplantation, 91
cost of Final Rule, 127, 129
donor characteristics as risk factors, 93
risk associated with increased allocation areas, 123
risk reduction, 92
Routine notification legislation, 57
S
Severity of illness
access issues in small transplant centers, 43
allocation criteria, 10, 35, 36-37
classification system, 4
cost of transplantation related to, 13, 127-129
current inadequacies in assessment, 24
current organ allocation process, 5, 6
in determination of organ acceptability, 93
effects of increased allocation areas, 1, 7
outcomes analysis method, 66-68
posttransplant survival rate and, 98
standardized criteria for defining, 26
variation in outcomes, 68, 78
waiting time and, 1, 10-11, 35, 61-62
See also specific status level of patient
Socioeconomic differences
access to transplantation, 2, 39-40, 41
policy development to reduce, 26
in posttransplantation compliance, 41
Sources of donated organs, 49
determination of organ acceptability, 93
State laws and policies, 27
mandated referrals for organ donation, 56-57
Medicaid, 45-46
Status 4 patient outcomes, 74
Status 1 patients
access issues in small transplant centers, 43
allocation criteria, 10
characteristics of patients, 62, 69
clinical features, 4
cost of transplantation, 13, 127-128
current allocation process, 5
effects of increased organ allocation areas, 1, 7, 87-88, 96
effects of OPO sharing on transplant outcomes, 82
length of stay, 127-128
OPO size as outcome factor, 78, 81
posttransplantation mortality risk, 69, 70, 98
pretransplantation mortality risk, 68, 69-70, 71-72
transplantation rate among, 1, 69, 78, 86, 87
waiting time, 10, 61-62, 66, 68, 69, 86
Status 2 patients
access issues in small transplant centers, 43
age as outcome factor, 72
allocation criteria, 10, 11, 90
characteristics of patients, 62
clinical features, 4
cost of transplantation, 13, 128
current allocation process, 5
effects of increased organ allocation areas, 1, 7, 87-89
effects of OPO sharing on transplant outcomes, 85
length of stay, 128
OPO size as outcome factor, 81
outcome predictors, 6
posttransplantation mortality risk, 72, 98
pretransplantation mortality risk, 68, 72, 74, 76, 87
transplantation rate among, 1, 72, 74, 76, 86, 87
waiting time, 10, 61-62, 66, 68, 72, 74, 86
Status 3 patients
age as outcome factor, 76
allocation criteria, 10, 11, 90
characteristics of patients, 62
clinical features, 4
cost of transplantation, 13, 128
current allocation process, 5
effects of increased organ allocation areas, 1, 7, 87-89, 96
effects of OPO sharing on transplant outcomes, 85
length of stay, 128
OPO size as outcome factor, 81
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outcome predictors, 6
posttransplantation mortality risk, 74
pretransplantation mortality risk, 68, 74, 87
transplantation rate among, 1, 74, 76, 78, 86, 87
waiting time, 10, 61-62, 66, 68, 74, 86
Steatotic livers, 92
Surgical procedures, 129
Survival rate, posttransplant
biological factors in organ function, 91
data sources, 96, 98
Final Rule effects on, 12-13, 27-28, 91
method of analysis, 66-68
national organ sharing and, 96
OPO-specific risk factors, 98, 99
OPO volume related to, 12-13
racial differences, 42
risk factors, 98
status level of patient and, 98
trends, 17
variation among OPOs, 70
variations by patient status, 69, 70, 72, 74
waiting time and, 72
System of organ transplantation, 31
allocation process, 34-37
biological constraints, 94
computer simulation, 95-96
criticisms of governance structure, 38, 131
data collection and performance monitoring, 95, 131-135
evolution of, 18-23
federal role, 131-132
liver transplantation as representative of, 23
local variation, 22, 23
participants, 49
recommendations for, 14
scientific review of, 133
transplant centers and programs, 22
T
Training of medical professionals, 26
Transplantation centers
costs of organ procurement, 129-130
data collection, 95
definition, 32
number of, 22
performance standards, 132, 133
small, effects of Final Rule on, 43-45, 46
Transplantation programs, 3-4
definition, 32
estimated charges, 124
number of, 22
Transplantation utilization, 2
trends, 17
Transportation of patient
as barrier to utilization, 44-45
Medicaid coverage, 45-46
Transportation of procured organ
costs, 13, 123, 129-130
Transportation of surgical team, 129
U
United Network for Organ Sharing (UNOS)
criticisms of governance structure, 38
current structure, 22, 31
data collection and management, 134
function, 5, 31
liver allocation policy, 36-37
membership, 31
policy development, 31
Utilization
number of transplantations, 2, 17
patient's travel distance as factor in, 44-45
trends, 17
W
Waiting list, 2, 17-18
enrollment process, 3-4
Final Rule goals, 24, 26
management of, 5
multiple listings for same patient, 36
Waiting time
as allocation criterion, 10-11, 35, 87, 88-89, 90
current concerns, 1, 61
definition, 61
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determinants of, 27
fairness issues, 2
Final Rule goals, 26
Final Rule review, 3, 27-28, 61
as indicator of system performance, 1, 7, 10, 61, 88
method of analysis, 66-68
racial differences, 40
regional variation, 23, 61, 62
socioeconomic differences, 39-40
transfer to another transplant center, 36
transplant outcomes and, 72, 74, 76, 86, 89
variation among OPOs, 61, 67, 68, 72, 74, 86, 88-89
variations by patient status, 68, 69, 72, 74, 86, 88-89
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